The instant invention relates generally to novel construction for a urinary catheter device. More specifically, the present invention relates to a urinary catheter device that includes a backflow prevention valve that is located in the catheter tube at a point outside the patient's body, providing improved construction and a safer location relative to the prior art devices.
Catheters and other devices for use in the draining of accumulated fluids from the human body or injecting fluids into the body have been widely used in the medical field for a long period of time. In particular, with reference to catheters, there are numerous constructions and designs, each of which is particularly adapted to be inserted into a particularly designated body cavity. For example, a urethral catheter is designed to drain accumulated urine secretions from the bladder. A ventricular catheter is adapted to drain excess cerebrospinal fluid from the brain. A peritoneal catheter is used to drain fluid from the peritoneum; as in kidney dialysis. An enema catheter is used to introduce fluid into the gastrointestinal tract.
All of the above-mentioned types of catheters, as well as others too numerous to enumerate, all have certain design features in common. A typical catheter is formed of hollow, flexible tubing. The tubing is typically comprised of a silicone elastomer such as silicone rubber, a substance which is soft and non-irritating to body tissues. A typical catheter will have a body contact that is designed for insertion into the body and a non-body contact end. One or more inlets are formed proximal to the body contact end. Corresponding outlets will be formed adjacent the non-body contact end, and frequently will be the non-body contact end itself. Catheters designed for different purposes may additionally comprise other structures, but the ones enumerated are generally common to all catheters. Also, the dimensions of the catheter may vary greatly and will be adapted to the purpose for which it is intended. For example, a catheter adapted as a urinary catheter may typically have an outside diameter in the range of 3-8 millimeters. In contrast, a ventricular catheter will have a much smaller diameter.
No matter the particular type, most catheters are used in a similar manner. One end of the catheter is inserted into the body cavity containing the fluid that needs to be drained. The catheter may be inserted directly through a body orifice, such as is the usual case with urethral catheters, or a special opening may have to be made. For example, an opening may have to be made into a vein and the catheter threaded through the vein until it reaches the target body cavity, such as is the case with ventricular catheters. After the catheter is inserted, some means of collecting the fluid must be attached to the non-body contact end. Sometimes, as for ventricular catheters, the catheter will remain entirely within the body and the excess fluid drained will be absorbed by another area of the body. More commonly, however, the excess fluid will simply be collected in a bag or bottle and discarded. The catheter may be left in place for long periods, or the excess body fluid may be drained quickly and the catheter removed after only a short period of insertion.
Further, the structure of catheters may vary relative to the number of simultaneous functions they are designed to perform. Catheters that include one, two or three separate longitudinal passageways, referred to as lumens, are available. Each of these multiple lumen catheters all include a primary lumen that serves as a drainage passageway. A second lumen is provided as a passageway by which to inject air that inflates a balloon on the inserted end of the catheter, thereby retaining the catheter in the patient. Finally, a third lumen may be provided as a means for injecting irrigation water into the cavity for cleansing purposes.
Irrespective of what type of catheter is used, how long it remains in place, or what type of body fluid it is used to drain, all catheters are designed for the single purpose of allowing fluid to drain out of the body cavity into which they are inserted. The difficulty is that as described above, the catheter tube is connected at the outflow end to a collection container. If the catheter remains in place for a period of time, the possibility exists that, should the collection container be crushed or raised above the level of the body cavity being drained, the drained fluid may flow in reverse and reenter the cavity from which it was drained. This is of particular concern in cases where the catheter may be inserted for long periods for constant cavity drainage. In these cases, the drained fluid may remain in the drainage container for several hours allowing the growth of harmful bacteria. Should this fluid be reintroduced to the body cavity serious or even deadly infections could result.
While one prior art catheter disclosed a one-way check valve in the drainage lumen, the valve was located proximal to the insertion end of the catheter. The placement and design of the valve were formulated primarily to retain any fluid that may be within the catheter during withdrawal and disposal. In this manner, the valve prevented fluid from flowing out of the withdrawn catheter onto the floor or more importantly onto the medical professional handling the catheter. However, this valve design is only appropriate for the stated function and several drawbacks with respect to the need identified for the present invention. First, because of the size and location of the valve, in the narrowest diameter of the catheter, the passageway becomes very susceptible to blockage. Second, the valve is located within the patient allowing the potential of drained material for flowing into the patient. Finally, if this valve configuration is used in a double or single lumen design, the catheter cannot be used of irrigation because the valve would block the flow of injected irrigation fluid.
There is therefore a need for a new catheter design that provides for a backflow prevention means that does not allow the flow of drained material to re-enter the body of the patient while also providing a positively locking assembly that further facilitates the delivery of irrigation to the patient should the need arise.